{
    "info": {
        "nct_id": "NCT04725331",
        "official_title": "A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.",
        "inclusion_criteria": "* Have at least 1 injectable measurable cutaneous, subcutaneous or nodal lesion (direct injection or through the use of ultrasound guidance) not exceeding 50mm in longest diameter and whenever possible 1 distant non-injected measurable lesion.\n* Provision of a fresh tumor sample of the lesion that will be injected first and, whenever possible, from another lesion that is planned to be injected, at baseline and be willing to supply new tumor samples from a biopsy during treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Have adequate hematological, hepatic and renal functions.\n* Have histologically confirmed, advanced/metastatic sarcoma (soft tissue and bone), Merkel cell carcinoma, melanoma, triple negative breast cancer or non-small cell lung cancer, with cutaneous or, palpable subcutaneous lesions or easily injectable lymph nodes.\n* Have failed and/or are intolerant to standard therapeutic options.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Have had major surgery within 4 weeks of first study drug administration.\n* Have received prior treatment with a vaccinia oncolytic virus.\n* Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the start of treatment.\n* Have received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 28 days prior the first dose of study drugs\n* Have a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Have a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease\n* Have an active infection requiring systemic therapy\n* Have a known history of HIV infection\n* Is taking an anticoagulant medication that cannot be interrupted prior to IT injections\n* Have had an allogenic tissue/solid organ transplant or allogenic stem cell or bone marrow transplantation\n* History of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation.\n* Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE).\n* Have known active CNS metastases and/or carcinomatous meningitis.\n* Have a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.n.\n* Woman of childbearing potential who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment.\n* Have received or receiving any live or live-attenuated vaccine within 30 days prior to the first dose of study intervention..\n* History of myocarditis or congestive heart failure, unstable angina, uncontrolled infection, or myocardial infarction 6 months prior to clinical trial entry.\n* Interstitial lung disease that is symptomatic and may interfere with the detection or management of suspected drug-related pulmonary toxicity\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n* Have severe hypersensitivity to the active substance or, to any of the excipients of (≥Grade 3) to pembrolizumab. and/or any of its excipients",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have at least 1 injectable measurable cutaneous, subcutaneous or nodal lesion (direct injection or through the use of ultrasound guidance) not exceeding 50mm in longest diameter and whenever possible 1 distant non-injected measurable lesion.",
            "criterions": [
                {
                    "exact_snippets": "at least 1 injectable measurable cutaneous, subcutaneous or nodal lesion",
                    "criterion": "injectable measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "cutaneous",
                                "subcutaneous",
                                "nodal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not exceeding 50mm in longest diameter",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "whenever possible 1 distant non-injected measurable lesion",
                    "criterion": "distant non-injected measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provision of a fresh tumor sample of the lesion that will be injected first and, whenever possible, from another lesion that is planned to be injected, at baseline and be willing to supply new tumor samples from a biopsy during treatment.",
            "criterions": [
                {
                    "exact_snippets": "Provision of a fresh tumor sample of the lesion that will be injected first",
                    "criterion": "fresh tumor sample of the lesion that will be injected first",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "whenever possible, from another lesion that is planned to be injected",
                    "criterion": "tumor sample from another lesion that is planned to be injected",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at baseline",
                    "criterion": "tumor sample at baseline",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be willing to supply new tumor samples from a biopsy during treatment",
                    "criterion": "new tumor samples from a biopsy during treatment",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have adequate hematological, hepatic and renal functions.",
            "criterions": [
                {
                    "exact_snippets": "adequate hematological ... functions",
                    "criterion": "hematological function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... hepatic ... functions",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have histologically confirmed, advanced/metastatic sarcoma (soft tissue and bone), Merkel cell carcinoma, melanoma, triple negative breast cancer or non-small cell lung cancer, with cutaneous or, palpable subcutaneous lesions or easily injectable lymph nodes.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced/metastatic sarcoma (soft tissue and bone), Merkel cell carcinoma, melanoma, triple negative breast cancer or non-small cell lung cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "advanced/metastatic sarcoma (soft tissue and bone)",
                                "Merkel cell carcinoma",
                                "melanoma",
                                "triple negative breast cancer",
                                "non-small cell lung cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cutaneous or, palpable subcutaneous lesions or easily injectable lymph nodes",
                    "criterion": "lesion or lymph node condition",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "cutaneous",
                                "palpable subcutaneous lesions",
                                "easily injectable lymph nodes"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have failed and/or are intolerant to standard therapeutic options.",
            "criterions": [
                {
                    "exact_snippets": "Have failed ... standard therapeutic options.",
                    "criterion": "response to standard therapeutic options",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "are intolerant to standard therapeutic options.",
                    "criterion": "tolerance to standard therapeutic options",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Have had major surgery within 4 weeks of first study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Have had major surgery within 4 weeks of first study drug administration.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received prior treatment with a vaccinia oncolytic virus.",
            "criterions": [
                {
                    "exact_snippets": "Have received prior treatment with a vaccinia oncolytic virus",
                    "criterion": "prior treatment with a vaccinia oncolytic virus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the start of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the start of treatment.",
                    "criterion": "prior systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis",
            "criterions": [
                {
                    "exact_snippets": "Have received prior radiotherapy within 2 weeks of start of study treatment",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have had a history of radiation pneumonitis",
                    "criterion": "radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 28 days prior the first dose of study drugs",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving chronic systemic steroid therapy ... exceeding 10 mg daily of prednisone equivalent",
                    "criterion": "chronic systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily of prednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy within 28 days prior the first dose of study drugs",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days prior the first dose of study drugs"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a known additional malignancy that is progressing or has required active treatment within the past 3 years.",
            "criterions": [
                {
                    "exact_snippets": "known additional malignancy",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).",
            "criterions": [
                {
                    "exact_snippets": "active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required systemic treatment in past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "history of (non-infectious) pneumonitis / interstitial lung disease",
                    "criterion": "history of non-infectious pneumonitis or interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required steroids",
                    "criterion": "requirement of steroids for pneumonitis or interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis / interstitial lung disease",
                    "criterion": "current pneumonitis or interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a known history of HIV infection",
            "criterions": [
                {
                    "exact_snippets": "known history of HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is taking an anticoagulant medication that cannot be interrupted prior to IT injections",
            "criterions": [
                {
                    "exact_snippets": "taking an anticoagulant medication",
                    "criterion": "anticoagulant medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be interrupted prior to IT injections",
                    "criterion": "interruption of anticoagulant medication",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have had an allogenic tissue/solid organ transplant or allogenic stem cell or bone marrow transplantation",
            "criterions": [
                {
                    "exact_snippets": "allogenic tissue/solid organ transplant",
                    "criterion": "allogenic tissue/solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "allogenic stem cell or bone marrow transplantation",
                    "criterion": "allogenic stem cell or bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation.",
            "criterions": [
                {
                    "exact_snippets": "History of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis)",
                    "criterion": "severe exfoliative skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring systemic therapy for more than 4 weeks",
                    "criterion": "systemic therapy duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 2 years prior to BT-001 initiation",
                    "criterion": "timeframe since condition",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE).",
            "criterions": [
                {
                    "exact_snippets": "Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent",
                    "criterion": "prior therapy with anti-PD-1, anti-PD-L1, or anti PD L2 agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)",
                    "criterion": "prior therapy with agent directed to stimulatory or co-inhibitory T-cell receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE)",
                    "criterion": "discontinuation due to immune-related Adverse Event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have known active CNS metastases and/or carcinomatous meningitis.",
            "criterions": [
                {
                    "exact_snippets": "known active CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.n.",
            "criterions": [
                {
                    "exact_snippets": "known history of Hepatitis B (defined as HBsAg reactive)",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HBsAg status",
                            "expected_value": "reactive"
                        }
                    ]
                },
                {
                    "exact_snippets": "known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected)",
                    "criterion": "Hepatitis C virus",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HCV RNA [qualitative]",
                            "expected_value": "detected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Woman of childbearing potential who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Woman of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive serum pregnancy test (within 72 hours) prior to the start of treatment",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours prior to the start of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received or receiving any live or live-attenuated vaccine within 30 days prior to the first dose of study intervention..",
            "criterions": [
                {
                    "exact_snippets": "received or receiving any live or live-attenuated vaccine within 30 days prior to the first dose of study intervention",
                    "criterion": "live or live-attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of myocarditis or congestive heart failure, unstable angina, uncontrolled infection, or myocardial infarction 6 months prior to clinical trial entry.",
            "criterions": [
                {
                    "exact_snippets": "History of myocarditis",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction 6 months prior to clinical trial entry",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interstitial lung disease that is symptomatic and may interfere with the detection or management of suspected drug-related pulmonary toxicity",
            "criterions": [
                {
                    "exact_snippets": "Interstitial lung disease that is symptomatic",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may interfere with the detection or management of suspected drug-related pulmonary toxicity",
                    "criterion": "interference with detection or management of drug-related pulmonary toxicity",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Is currently participating in or has participated in a study of an investigational agent",
                    "criterion": "participation in a study of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has used an investigational device within 4 weeks prior to the first dose of study treatment",
                    "criterion": "use of an investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have severe hypersensitivity to the active substance or, to any of the excipients of (≥Grade 3) to pembrolizumab. and/or any of its excipients",
            "criterions": [
                {
                    "exact_snippets": "severe hypersensitivity to the active substance or, to any of the excipients of (≥Grade 3) to pembrolizumab",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": ">=Grade 3"
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": [
                                "active substance",
                                "excipients of pembrolizumab"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}